Medical Devices

ISO 13485:2016

Quality Requirements for Medical Devices

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Quality Management System

What is ISO 13485?

The international standard, ISO 13485:2016 Medical Devices – Quality Management Systems Requirements for regulatory purposes identifies the requirements for a quality management system that is used by an organization involved in one or more stages of the life-cycle of a medical device, including the design and development,
production, storage and distribution, installation, servicing, final decommissioning and disposal of a medical device, design and development, or provision of associated activities.

While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented Quality Management System.

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Medical Device Establishments

The Medicines and Related Substances Act 101 of 1965, read in conjunction with the General Regulations on Medical Devices states that the license to manufacture, import & export or to distribute must be satisfied by the prescribed requirements. The authorised representative must be able to provide certified evidence of certification to a Quality Management System as determined by the Council. The regulatory authority in South Africa is SAHPRA which acts as the Council. In a communication issued by SAHPRA, it was stipulated that ISO 13485 is the appropriate Quality Management System that medical device establishments must be certified against for license issue and renewal.


Take Note

*A manufacturer, distributor, wholesaler of a non-sterile, non-measuring Class A medical device does not need to apply for license.

 *Medical device establishments that use a third-party storage must ensure that the third-party company has an approved license.

There are 3 types of medical device establishments that licenses are issued to depending on the activities performed.


The scope covered includes any packaging, labelling, servicing or refurbishment of medical devices in addition to design and development and the assembling of medical devices or IVDs. The scope of these activities also include import, distribution, export activities for medical devices/IVDs. ISO 13485 is mandatory for the issue/renewal of manufacturing licenses. A Quality Management System is required.


The scope covered includes importing, exporting or distributing medical devices and IVDs. ISO 13485 is mandatory for the issue/renewal of distributors licenses. A Quality Management System is required.


The scope of activities include the procurement of medical devices from a local manufacturer or the sale of them to a retailer or distributor, not inclusive of importing or exporting. ISO 13485 is not mandatory for the issue/renewal of wholesaler licenses, however, external parties may request some form of certification/compliance for end user assurance. A Site Master File required, however a Quality Management System is considered as best practice.

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QMS is critical

The Importance of ISO 13485

ISO 13485 provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. It can also help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer’s reputation & marketability.
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies.

The Process Approach

Rather than focusing on each individual clause of the standard, read the requirements in terms of inputs and outputs. ISO 13485 uses the Plan, Do, Check, Act methodology; each key area of the standard, such as quality system, management responsibility, resource management, product realization, and measurement, must be read in terms of inputs to the requirement (i.e. resource requirements) and outputs to the requirement (i.e. measurements). Only through careful study and understanding of the process model can you achieve this effective thinking approach.

Quality Management System

What is ISO 13485?

JC Auditors stands out as a premier choice for ISO 13485 certification due to their extensive experience and expertise in the auditing domain spanning over 16 years. With a proven track record of excellence, JC Auditors has established itself as a trusted partner for organizations seeking to achieve compliance with ISO 13485 standards.

Their seasoned auditors possess in-depth knowledge of regulatory requirements and industry best practices, enabling them to conduct thorough assessments and provide invaluable insights to clients. JC Auditors is committed to delivering tailored solutions that align with each client’s unique needs, ensuring a smooth and efficient certification process.

By choosing JC Auditors, organizations can confidently navigate the complexities of ISO 13485 certification, secure in the knowledge that they are partnering with a reputable auditing firm dedicated to their success.